MR- PET Guided Biologically Optimised Interstitial Brachytherapy (MR-PET Brachy)

April 3, 2020 updated by: Supriya Sastri (chopra), Tata Memorial Hospital

MR-PET Guided Biologically Optimised Interstitial Brachytherapy for Postoperative Recurrent Cervical Cancers

The proposed two stage study will evaluate patterns of local recurrence after EBRT and brachytherapy in spatial reference to baseline functional MRI and FLT/F-Miso PET scan in patients undergoing chemoradiotherapy for postoperative recurrences of cervical cancer. The first stage of the study will focus on developing MR guided interstitial brachytherapy and validating the concept of high risk gross tumor volume (on the basis of functional imaging features).

The second stage thereafter will focus on developing biologically modulated interstitial brachytherapy.

In the proposed two staged study the investigators intend to prospectively evaluate and validate concept of HRGTV and develop technique of biologically dose modulated brachytherapy. The demonstration of technical feasibility and clinical safety of biologically modulated image guided radiotherapy in this pilot study for may pave the way for improving local control in patients with postoperative recurrences.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aims

Stage I

Aim 1: To spatially characterize biologically heterogenous subvolumes within the gross tumor through multimodality (18 F-Miso/FLT/Functional MR) image fusion.

Aim 2: To evaluate post external beam radiotherapy (EBRT) response in spatial reference to biological heterogeneous sub-volumes on imaging.

Stage II:

Aim 3: To evaluate technical feasibility of delivering dose modulated biologically optimized interstitial brachytherapy.

Aim 4: To evaluate acute and late toxicity and quality of life associated with biologically optimized brachytherapy

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Navi Mumbai, Maharashtra, India, 410210
        • Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age > 18 years.
  • ECOG 0 or 1.
  • Residual/ Recurrent tumor after hysterectomy of cervical cancer.
  • No visceral metastasis.
  • No known contraindication to contrast enhanced MRI/PET scan.
  • Fit for radical treatment (radiotherapy+/-chemotherapy).

Exclusion Criteria:

  • Expected survival less than 3 years due to coexisting morbid medical conditions precluding radical chemoradiotherapy.
  • Inguinal or extra-pelvic nodal metastasis (Patients with common iliac nodal enlargement in the absence of paraaortic nodal metastasis on PET-CT may be included in the study).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
The study arm will undergo baseline multifunctional PET and MRI scans, before brachytherapy and at follow up
Radiation: MR PET Guided Brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Local Response in spatial reference to High Risk GTV (as identified by functional imaging)
Time Frame: 3 months after treatment completion
3 months after treatment completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Grade III rectal and bladder toxicity with biologically dose modulated brachytherapy
Time Frame: 2 years after treatment conclusion
Stage II involves dose modulated brachytherapy wherein higher dose will be delivered to biologically high risk target volume. Saftey will be assessed initially by an interim analysis undertaken at 50 % accrual(median follow up 1 yr). If incidence of grade III-IV rectal and bladder toxicity >15% than the trial will be stopped else continued till target accrual. The technique will be considered to be safe if Grade III bladder and bowel toxicity remain to be under 15%.
2 years after treatment conclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2011

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

October 4, 2019

Study Registration Dates

First Submitted

July 1, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMH-IRB 843

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Published article

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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